What is clinical research?
What is the role of NIH and
NHLBI in clinical research?
What are the Project
Officer's responsibilities in clinical research?
What is the role of the
Principal Investigator/Institution in clinical research?
How can I find funding opportunities (RFAs, RFPs and PAsG)?
What do I need to know before submitting a clinical research application?
Am I a new investigator and what if this is my first NIH application?
Which NHLBI staff can help me?
Is my study considered clinical research?
Is my study observational or interventional?
What is the best award mechanism for my clinical research proposal?
What if my project exceeds $500,000 in direct costs in any given year?
Where can I get help with writing the application?
What must I include in "Protection of Human Subjects"?
How and when do I submit my application?
What happens to my grant after submission?
Who will review my application and when?
Did the reviewers like my application?
What is a summary statement and what does it mean?
What if I don't agree with the review?
How do I know if I am funded?
Who needs human subjects protection training?
Who approves my data monitoring plan?
What is a Certificate of Confidentiality and do I need one?
How do I develop consent forms and who reviews them?
Are there ethical concerns and conflicts of interest I must consider?
Do I need IRB, IEC or REB approval?
What other approvals are needed?
How do I track recruitment of research participants?
My study involves Medicare or third party support.
My study involves foreign grants and contracts.
How do I register my study?
When can I begin enrolling participants?
How do I comply with Good Clinical Practices (GCP)?
How do I manage changes to my grant?
How do I report amendments, suspensions and terminations?
Must I obtain continuing review from the IRB?
Who should monitor subject recruitment/retention?
How do I report adverse events?
How is data quality monitored?
What if I wish to add extra sites or studies to my project?
How do I manage my budget and when are reports expected?
What is HIPAA and how do I abide by the requirements ?